Short-term linaclotide plus polyethylene glycol in patients at increased risk of inadequate bowel preparation: A randomized, double-blind, multicenter trial.

Chen H, Wang J, Fan C, Zhuang K, Yuan L, Li H, Jing Y, Fang N, Dong J, Han Y, Liu Z

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver14 Feb 2026

PMID41692643DOI10.1016/j.dld.2026.01.229PepBankPUB-41692643

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In at-risk patients, linaclotide did not significantly improve adequate bowel preparation versus placebo with PEG in the modified intention-to-treat analysis.
In plain wordsIn at-risk patients, adequate bowel preparation did not differ significantly between linaclotide and placebo with PEG.
Peptide
Linaclotide
Outcome
No significant changeAdequate bowel preparation, modified intention-to-treat
Study
n = 672
Comparator
Placebo plus PEG
Analysis
Primary
Outcome group
Bowel Preparation · Gastrointestinal
Studied dose
Dose not stated · 2 daysAs given in this study (human).
Measurements
Odds ratio
1.26 NA
mITT; 95% CI 0.73-2.16
P value
0.406 NA
mITT
Source sentences
Summary
The modified intention-to-treat (mITT) (n=672) and per-protocol (n=574) analyses showed no significant differences in adequate bowel preparation rates (mITT: OR 1.26, 95% CI 0.73-2.16, P=0.406; per-protocol: OR 1.46, 95% CI 0.80-2.66, P=0.222)
2 context sentences(design, population, supporting numbers)
Summary · context
From August 2022 to July 2023, a multicenter, randomized trial assigned participants to a 2-day linaclotide or placebo plus PEG regimen.
Summary · context
The primary endpoints included adequate bowel preparation rate and mean number of adenomas detected per colonoscopy.
Report a problemFND-4169264301
02HumanRandomized controlled trialEfficacy outcome
In at-risk patients, mean adenoma counts did not differ significantly between linaclotide and placebo with PEG in the modified intention-to-treat analysis.
In plain wordsIn at-risk patients, adenoma counts did not differ significantly between linaclotide and placebo with PEG.
Peptide
Linaclotide
Outcome
No significant changeMean adenoma count, modified intention-to-treat
Study
n = 672
Comparator
Placebo plus PEG
Analysis
Primary
Outcome group
Bowel Preparation · Gastrointestinal
Studied dose
Dose not stated · 2 daysAs given in this study (human).
Measurements
Mean difference
−0.02 adenomas
mITT; 95% CI -0.19-0.15
P value
0.832 NA
mITT
Source sentences
Summary
or the mean number of adenomas (mITT: mean difference -0.02, 95% CI -0.19-0.15, P=0.832; per-protocol: mean difference -0.06, 95% CI -0.25-0.13, P=0.530) between groups.
2 context sentences(design, population, supporting numbers)
Summary · context
From August 2022 to July 2023, a multicenter, randomized trial assigned participants to a 2-day linaclotide or placebo plus PEG regimen.
Summary · context
The primary endpoints included adequate bowel preparation rate and mean number of adenomas detected per colonoscopy.
Report a problemFND-4169264303
03HumanRandomized controlled trialEfficacy outcome
In at-risk patients, linaclotide did not significantly improve adequate bowel preparation versus placebo with PEG in the per-protocol analysis.
In plain wordsIn at-risk patients, per-protocol preparation adequacy did not differ significantly between linaclotide and placebo with PEG.
Peptide
Linaclotide
Outcome
No significant changeAdequate bowel preparation, per-protocol
Study
n = 574
Comparator
Placebo plus PEG
Analysis
Primary
Outcome group
Bowel Preparation · Gastrointestinal
Studied dose
Dose not stated · 2 daysAs given in this study (human).
Measurements
Odds ratio
1.46 NA
per-protocol; 95% CI 0.80-2.66
P value
0.222 NA
per-protocol
Source sentences
Summary
The modified intention-to-treat (mITT) (n=672) and per-protocol (n=574) analyses showed no significant differences in adequate bowel preparation rates (mITT: OR 1.26, 95% CI 0.73-2.16, P=0.406; per-protocol: OR 1.46, 95% CI 0.80-2.66, P=0.222)
2 context sentences(design, population, supporting numbers)
Summary · context
From August 2022 to July 2023, a multicenter, randomized trial assigned participants to a 2-day linaclotide or placebo plus PEG regimen.
Summary · context
The primary endpoints included adequate bowel preparation rate and mean number of adenomas detected per colonoscopy.
Report a problemFND-4169264302
04HumanRandomized controlled trialEfficacy outcome
In at-risk patients, mean adenoma counts did not differ significantly between linaclotide and placebo with PEG in the per-protocol analysis.
In plain wordsIn at-risk patients, per-protocol adenoma counts did not differ significantly between linaclotide and placebo with PEG.
Peptide
Linaclotide
Outcome
No significant changeMean adenoma count, per-protocol
Study
n = 574
Comparator
Placebo plus PEG
Analysis
Primary
Outcome group
Bowel Preparation · Gastrointestinal
Studied dose
Dose not stated · 2 daysAs given in this study (human).
Measurements
Mean difference
−0.06 adenomas
per-protocol; 95% CI -0.25-0.13
P value
0.53 NA
per-protocol
Source sentences
Summary
or the mean number of adenomas (mITT: mean difference -0.02, 95% CI -0.19-0.15, P=0.832; per-protocol: mean difference -0.06, 95% CI -0.25-0.13, P=0.530) between groups.
2 context sentences(design, population, supporting numbers)
Summary · context
From August 2022 to July 2023, a multicenter, randomized trial assigned participants to a 2-day linaclotide or placebo plus PEG regimen.
Summary · context
The primary endpoints included adequate bowel preparation rate and mean number of adenomas detected per colonoscopy.
Report a problemFND-4169264304
05HumanRandomized controlled trialEfficacy outcome
In at-risk patients, linaclotide plus PEG increased mean right-colon polyp counts versus placebo plus PEG, at 0.54 versus 0.27.
In plain wordsIn at-risk patients, linaclotide plus PEG detected more right-colon polyps than placebo plus PEG.
Peptide
Linaclotide
Outcome
IncreaseRight-colon polyp count
Study
n: not reported in source
Comparator
Placebo plus PEG
Outcome group
Bowel Preparation · Gastrointestinal
Studied dose
Dose not stated · 2 daysAs given in this study (human).
Measurements
Polyp count
0.54 polyps
linaclotide; SD 1.9
Polyp count
0.27 polyps
placebo; SD 0.8
Reported mean difference
−0.27 polyps
95% CI -0.49- -0.05; P=0.016
Source sentences
Summary
However, linaclotide and PEG increased the mean number of polyps in the right colon (0.54 ± 1.9 vs. 0.27 ± 0.8; mean difference -0.27, 95% CI -0.49- -0.05, P=0.016),
2 context sentences(design, population, supporting numbers)
Summary · context
From August 2022 to July 2023, a multicenter, randomized trial assigned participants to a 2-day linaclotide or placebo plus PEG regimen.
Summary · context
The primary endpoints included adequate bowel preparation rate and mean number of adenomas detected per colonoscopy.
Report a problemFND-4169264305
06HumanRandomized controlled trialEfficacy outcome
In at-risk patients aged ≥70 years, linaclotide plus PEG increased right-colon polyp detection versus placebo plus PEG (P=0.033).
In plain wordsIn at-risk patients aged ≥70 years, linaclotide plus PEG detected more right-colon polyps than placebo plus PEG.
Peptide
Linaclotide
Outcome
IncreaseRight-colon polyp count in patients aged at least 70
Study
n: not reported in source
Comparator
Placebo plus PEG
Outcome group
Bowel Preparation · Gastrointestinal
Studied dose
Dose not stated · 2 daysAs given in this study (human).
Measurements
Reported mean difference
−1.3 polyps
age ≥70 years; 95% CI -2.48- -0.13; P=0.033
Source sentences
Summary
However, linaclotide and PEG increased the mean number of polyps in the right colon (0.54 ± 1.9 vs. 0.27 ± 0.8; mean difference -0.27, 95% CI -0.49- -0.05, P=0.016), particularly in patients aged ≥70 years (mean difference -1.30, 95% CI -2.48- -0.13, P=0.033).
2 context sentences(design, population, supporting numbers)
Summary · context
From August 2022 to July 2023, a multicenter, randomized trial assigned participants to a 2-day linaclotide or placebo plus PEG regimen.
Summary · context
The primary endpoints included adequate bowel preparation rate and mean number of adenomas detected per colonoscopy.
Report a problemFND-4169264306

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

Subjects

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Short-term linaclotide plus polyethylene glycol in patients at increased risk of inadequate bowel preparation: A randomized, double-blind, multicenter trial.

Summary

Results from this study6

Version history

Subjects

Publication types

MeSH terms

Keywords